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Chemgenex completes NDA submission for its omacetaxine mepesuccinate to the FDA

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for OMAPRO™ (omacetaxine mepesuccinate). OMAPRO™ is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

9 Sep 2009

VIVUS' Phase 3 studies find Qnexa effective in tackling obesity

VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo.

9 Sep 2009

Protalix receives orphan drug designation for prGCD

Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the FDA’s Office of Orphan Products Development has granted orphan drug designation to prGCD, the Company’s proprietary plant cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.

8 Sep 2009

Shire's assistance helps Gaucher patients manage imiglucerase supply shortage

Shire plc, the global specialty biopharmaceutical company, is committed to doing everything possible to assist Gaucher patients and their physicians during the imiglucerase supply shortage. Shire is pleased to be able to provide velaglucerase alfa well over a year ahead of previously anticipated commercial launch world wide.

8 Sep 2009

Takeda receives FDA response regarding NDA for fixed-dose combination of alogliptin and ACTOS

Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl).

4 Sep 2009

Acurox's New Drug Application discussed with the FDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA).

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Phase I clinical trial data of GDC-0449 published in the New England Journal Of Medicine

Curis, Inc. (NASDAQ: CRIS), a drug development company focused on developing proprietary targeted medicines for cancer treatment, today announced that two publications describing clinical data generated with GDC-0449 were published in the current edition of The New England Journal of Medicine (NEJM).

3 Sep 2009

China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, today announced that it has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.

3 Sep 2009

Medtronic's COPE-HCV clinical study commences

Medtronic, Inc., today reported the initiation and first enrollments of patients in COPE-HCV (COntinuous Interferon Delivery via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV), the company’s first-ever clinical study using an external pump infusion system to treat patients with the hepatitis C virus (HCV).

3 Sep 2009

Two 2008 drug approval reports highlight Ceplene benefits

EpiCept Corporation today announced that Ceplene (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union.

3 Sep 2009

ODAC calls for randomized study of Vion's Onrigin injection for treatment of the elderly AML patients

VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the results of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for its lead oncology therapeutic Onrigin(TM)(laromustine) Injection were presented for the indication of remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).

3 Sep 2009

Biogen Idec's MS franchise to present at the 25th Congress of ECTRIMS

Biogen Idec today announced more than 70 platform and poster presentations from the company’s multiple sclerosis (MS) franchise being presented during the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

3 Sep 2009

Gloucester’s romidepsin recommended for approval by the FDA Oncologic Drug Advisory Committee

Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL). CTCL is a type of non-Hodgkin's lymphoma, which is a cancer of the immune system.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

National Cancer Institute awards grant to Receptor Logic for breast cancer research

Receptor Logic, Inc. announced today receipt of a Phase I Small Business Technology Transfer (STTR) Grant from the National Cancer Institute. The grant, entitled “Therapeutic Effectiveness of T-Cell Receptor mimic (TCRm™) Antibodies in Breast Cancer Treatment” will accelerate Investigational New Drug Application enabling studies surrounding lead candidate TCRm antibodies.

3 Sep 2009

Peplin announces merger agreement with LEO Pharma

Peplin, Inc. (ASX:PLI) today announced a definitive merger agreement whereby LEO Pharma A/S (LEO), a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, will acquire all outstanding securities of Peplin for approximately US$287.5 million (currently A$348.4 million) in cash. This represents a purchase price of US$16.99 per common share of Peplin stock or A$1.03 per Peplin CHESS Depositary Interest (CDI).

3 Sep 2009

FDA's Oncologic Drugs Advisory Committee votes in favor of FOLOTYN NDA

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

3 Sep 2009

Pfizer to pay $2.3 billion for health care fraud settlement

American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

3 Sep 2009

New Drug Application for VIMOVO accepted by U.S. Food and Drug Administration

POZEN Inc. (NASDAQ:POZN), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for VIMOVO™ (enteric-coated naproxen / immediate release esomeprazole magnesium, formerly know as PN 400).

31 Aug 2009